RecruitingPHASE1INTERVENTIONAL

A Phase I Open-Label, Single-Arm, Dose-Escalation Clinical and Pharmacology Study of CCI-001 as Monotherapy and in Combination With Standard Chemotherapy in Patients With Recurrent and/or Metastatic Solid Tumours

This research study is looking at a new drug called CCI-001 for people whose solid tumours (cancers that form solid lumps) have returned or spread. The study, called a Phase I trial, is the first time this drug will be tested in people. Its main goals are to check if the drug is safe, what side effects it might cause, and to find the best dose to give. Researchers also want to understand how the body uses and gets rid of the drug, and if it can help shrink tumours or stop them from growing for a time. Later parts of the study will involve people with specific types of gynaecological, pancreatic, lung, head and neck, bladder, and upper stomach/gut cancers, testing CCI-001 by itself or together with other cancer medicines.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

PharmaMatrix Holdings Ltd

Enrolment target

Start

26 Jul 2021

Estimated completion

01 Dec 2027

Cancer: Recurrent and/or Metastatic Solid Tumours

What is this study about?

This study is exploring a new medicine, called CCI-001, for people who have solid tumours that have come back after treatment or have spread to other parts of the body. Solid tumours are cancers that form a lump, for example, breast cancer, lung cancer, or bowel cancer. This is a very early-stage study, known as 'first-in-human' or Phase I, which means it's the first time the drug is being tested in people. The main aims are to understand its safety, any side effects it might cause, and to work out the best dose to use. We also want to see how the body takes in, uses, and removes the drug.

CCI-001 is a new type of drug that works by targeting something called 'tubulin' inside cancer cells. Tubulin is important for cell division, which is how cancer cells make more copies of themselves. This drug is designed to attach more strongly to a specific type of tubulin often found in many cancers, which could make it more effective against these cells. By stopping cells from dividing, the hope is that the drug will stop the cancer from growing.

Later on in the study, if the drug looks promising and safe, it will be tested in people with specific types of cancer that have spread or come back. These include gynaecological cancers (like ovarian, cervical, or endometrial cancer), pancreatic cancers, lung cancers, head and neck cancers, bladder cancer, and upper gut cancers (like oesophageal or stomach cancer). Some people might receive CCI-001 on its own, while others might get it alongside standard chemotherapy medicines like gemcitabine or cisplatin, to see if the combination works better.

Key takeaways

This study is testing a new drug, CCI-001, for advanced solid tumours.
It's a 'Phase I' study, focused on safety, side effects, and finding the best dose.
CCI-001 aims to stop cancer cells from dividing and growing.
Some participants may receive CCI-001 alone, others with standard chemotherapy.
Specific cancer types will be included in later parts of the study.
Participation involves regular monitoring for safety and effectiveness.

Who may be eligible?

To join this study, you must have solid tumours that have returned or spread. For most parts of the study, your cancer should have progressed on your last treatment, or you've tried most standard treatments, or there aren't any approved treatments for your specific cancer type. For one part of the study (Part 3), you must have progressed on your last treatment and had no more than three previous chemotherapy treatments.

You also need to be at least 18 years old. Your cancer must be measurable, which means doctors can clearly see and track the size of your tumours. If you've recently had chemotherapy, hormone therapy, targeted therapy, or radiotherapy, you'll need to wait at least four weeks before joining the study to allow your body to recover from any side effects, except for common ones like hair loss, mild sickness, or changes in bowel habits. For Part 3, only specific cancer types are included, and your doctors must believe your cancer might respond to the planned chemotherapy medicines (if you're getting them).

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have solid tumours that have returned or spread?
Am I at least 18 years old?
Has my cancer progressed on my last treatment, or have I tried most standard treatments?
Have I recovered from side effects of previous treatments (except hair loss, mild sickness, bowel changes)?
Can doctors clearly measure my tumours (e.g., on a scan)?
For Part 3, is my cancer one of the specific types listed (e.g., certain gynaecological, pancreatic, lung, head and neck, bladder, or upper gut cancers)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first need to give your informed consent, which means you agree to participate after fully understanding the study. You will then have several assessments, which might include scans to measure your tumour, blood tests, and physical examinations. You'll receive the study drug, CCI-001, either on its own or in combination with standard chemotherapy, depending on which part of the study you are in. The study team will explain how and when you'll receive the medication.

You'll have regular follow-up visits so the doctors can monitor how you are responding to the treatment and check for any side effects. These visits will likely involve repeated blood tests, scans, and discussions about your well-being. The treatment will continue for as long as it is benefiting you and you are not experiencing severe side effects. The total duration of your participation will depend on your individual response to the treatment, but the team will explain the typical schedule to you.

Potential risks and benefits

Potential benefits of joining this study include access to a new experimental drug that might help control your cancer, especially if standard treatments haven't worked or are no longer an option. However, being in a clinical trial doesn't guarantee your cancer will improve, and the drug might not work for everyone. As with all medicines, there are potential risks and side effects, some of which are unknown because this is a new drug. The study team will closely monitor you and explain all known potential side effects beforehand. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Cross Cancer Institute
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What does 'recurrent and/or metastatic solid tumours' mean?

It means your cancer, which formed a solid lump, has either come back after treatment or spread to other parts of your body.

What is a 'Phase I' trial?

This is the very first time a new drug is being tested in people. The main goals are to check if it's safe and to find the best dose.

What is CCI-001 and how does it work?

CCI-001 is a new drug designed to stop cancer cells from dividing and growing by targeting a specific protein inside them called tubulin.

Will I get CCI-001 by itself or with other treatments?

Depending on which part of the study you might join, you could receive CCI-001 on its own or along with standard chemotherapy medicines.

What are the main goals of this study?

The main goals are to understand if CCI-001 is safe, what dose works best, and to see how the body handles the drug. We also want to see if it helps against the cancer.

How to find out more

Charles Allard

crallard@shaw.ca 780-430-2811 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.